Prescription drug · ANDA
Nitroglycerin NDC 0404-9928
Nitroglycerin 5 mg/mL · Injection, Solution · Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9928-10 | 0040499281000404992810 | 1 VIAL in 1 BAG (0404-9928-10) / 10 mL in 1 VIALMarketed from Jan 13, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nitroglycerin
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072034
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 0404-9928_4d6839d6-a200-4bb6-ba39-6c52bb6a371fSPL ID 4d6839d6-a200-4bb6-ba39-6c52bb6a371fSPL set ID 578d8159-5ec6-457f-b4a8-9add624d43a8RxCUI 237205UNII G59M7S0WS3
- Pharmacologic class
- Nitrate Vasodilator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400404992810followed by a unit qualifier and the quantityPackage 00404-9928-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Indications and Usage Nitroglycerin Injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and b-blockers; and for induction of intraoperative hypotension.
Excerpt only. Read the full label for complete information.
About NDC 0404-9928
- What is NDC 0404-9928?
- 0404-9928 is the product NDC for Nitroglycerin, Nitroglycerin 5 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitroglycerin.
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitroglycerin?
- 69 other product NDCs are listed under this name. See all Nitroglycerin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitroglycerin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Padagis Israel Pharmaceuticals Ltd | 45802-932 | 45802-0932-94 |
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Bryant Ranch Prepack | 72162-2643 | 72162-2643-03 |
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Solaris Pharma Corporation | 73473-500 | 73473-0500-30 |
| Nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Solco Healthcare U.S., LLC | 43547-985 | 43547-0985-0443547-0985-10 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Solco Healthcare U.S., LLC | 43547-986 | 43547-0986-0443547-0986-10 |
| Nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Solco Healthcare U.S., LLC | 43547-987 | 43547-0987-0443547-0987-10 |
| Nitroglycerin | Nitroglycerin 20 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-054 | 21922-0054-0521922-0054-47 |
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4277 | 70518-4277-0070518-4277-01 |
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Encube Ethicals, Inc. | 21922-048 | 21922-0048-05 |
| Nitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1672 | 51662-1672-01 |
Other NDCs under ANDA 072034
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nitroglycerin | Nitroglycerin 5 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-4810 |
| Nitroglycerin | Nitroglycerin 5 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1386 |
| Nitroglycerin | Nitroglycerin 5 mg/mL | Injection, SolutionIntravenous | REMEDYREPACK INC. | 70518-4232 |